Clinical trials: Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML)
Acute Myeloid Leukemia, Mixed Lineage Leukemia Gene Mutation
A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Azacitidine, Venetoclax, 7+3, or 7+3+Quizartinib in Patients With AML
Ziftomenib is an investigational drug in development for the treatment of patients with acute myeloid leukemia (AML) with certain genetic alterations.
- Conditions
- Acute Myeloid Leukemia, Mixed Lineage Leukemia Gene Mutation, Refractory AML, AML With Mutated NPM1
- Trial name
- NCT05735184
- Testing
- Ziftomenib, Venetoclax, Azacitidine
- Where
- 44 sites in United States
- Volunteers
- 420 people
- Sponsor
- Kura Oncology, Inc.
Relapsed/Refractory Acute Myeloid Leukemia (AML)
Pilot Study of Crenolanib Combined With Standard Salvage Chemotherapy in Subjects With R/R AML
The proposed study is designed to combine crenolanib with standard salvage chemotherapy to treat patients with R/R AML irrespective the FLT3 status.
- Trial name
- NCT02626338
- Testing
- Crenolanib, Mitoxantrone, Cytarabine
- Where
- 4 sites in United States
- Volunteers
- 16 people
- Sponsor
- Arog Pharmaceuticals, Inc.
AML, Leukaemia (Acute Myeloid)
A Phase 2 Study of Gemtuzumab Ozogamicin (GO)-Gilteritinib Combination in Adults With FLT3-ITD and/or FLT3-TKD Relapse/Refractory (R/R) AML
This is a national, open-label, single-arm, multicenter phase II trial evaluating the safety and efficacy of adding gilteritinib, a new FLT3 inhibitor to the AGORA platform, consisting of the combination of an intermediate dose…
- Trial name
- AGORA-1 (NCT05199051)
- Testing
- Gemtuzumab ozogamicine - Cytarabine - Gilteritinib
- Where
- 12 sites in France
- Volunteers
- 19 people
- Sponsor
- Centre Antoine Lacassagne
ECG, Pharmacokinetics
Evaluating QTc, PK, Safety of Gemtuzumab Ozogamicin (GO) in Patients With CD33+ R/R AML
This is a single-arm, open-label, Phase 4 study evaluating the effect of GO on the QTc, pharmacokinetics, safety, and immunogenicity of GO as a single-agent monotherapy in adult and pediatric patients with relapsed or refractory…
- Conditions
- ECG, Pharmacokinetics, Safety
- Trial name
- NCT03727750
- Testing
- Gemtuzumab Ozogamicin
- Where
- 24 sites in United States, Canada and 4 more
- Volunteers
- 51 people
- Sponsor
- Pfizer
Acute Myeloid Leukemia
CAV Regimen for R/R AML
This study aims to investigate the efficacy and safety of cladribine, combined with low-dose cytarabine and venetoclax (CAV regimen) for relapsed/refractory acute myeloid leukemia (R/R AML).
- Trial name
- NCT05657639
- Testing
- CAV Regimen, MEC Regimen
- Where
- China
- Volunteers
- 68 people
- Sponsor
- The First Affiliated Hospital of Soochow University
Acute Myeloid Leukemia
Safety and Efficacy of Allogenic NK Cells in Combination With Chemotherapy in the Treatment of r/r AML After Allo-HSCT
This is an open label, single-arm, Phase I study to evaluate the efficacy and safety of allogenic natural killer(NK) cells in subjects with refractory or relapsed AML after allogeneic hematopoietic stem cell…
- Trial name
- NCT05744440
- Testing
- allogenic NK cells
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Xuzhou Medical University
Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)
ADCT-301 in Patients With R/R AML, MDS, or MDS/MPN
This is research study to find out if a drug called ADCT-301 is safe and to look at how patients respond to the study drug after an allogeneic transplantation.
- Conditions
- Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), Myeloproliferative Neoplasm (MDS/MPN)
- Trial name
- NCT04639024
- Testing
- ADCT-301
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Gwynn Long, M.D.
Relapsed/Refractory Acute Myeloid Leukaemia, Myeloid Malignancy
Mitoxantrone Hydrochloride Liposome Injection, Cytarabine Combined With Venetoclax in the Treatment of R/R AML
The goal of this study is to evaluate the efficacy and safety of a combination regimen of mitoxantrone hydrochloride liposome injection, cytarabine and venetoclax (MAV) in the treatment of relapsed or refractory (R/R) AML.
- Trial name
- NCT06434662
- Testing
- mitoxantrone hydrochloride liposome, Cytarabine, Venetoclax
- Where
- China
- Volunteers
- 34 people
- Sponsor
- First Affiliated Hospital of Zhejiang University
Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia Refractory
Off-the-shelf CD123 CAR-NK for R/R AML
This is a single-centre, single-arm, open-label, first-in-human (FIH) study to evaluate the safety, tolerability and preliminary efficacy of universal Off-the-shelf CAR-NK cells targeted CD123 (JD123 injection) in the treatment…
- Trial name
- NCT06201247
- Testing
- JD123 injection
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Peking University People's Hospital
Relapsed Adult AML
Study of Oral PCLX-001 in R/R Acute Myeloid Leukemia
This is a dose-finding study of oral zelenirstat (PCLX-001) in patients with R/R AML. There are two parts to the study: Dose Escalation and Dose Expansion.
- Trial name
- NCT06613217
- Testing
- zelenirstat
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Pacylex Pharmaceuticals
Leukemia, Acute Myeloid (AML)
HEC73543 Versus Salvage Chemotherapy in R/R FLT3-ITD AML
A randomized，multicenter, open-label Phase III, clinical study is conducted to evaluate the clinical benefit Clifutinib in Chinese patients with relapsed/ refractory (R/R) FLT3-mutated AML as shown with overall survival compared…
- Trial name
- NCT05586074
- Testing
- Clifutinib, LoDAC, Azacitidine
- Where
- China
- Volunteers
- 324 people
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Refractory Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia
Clinical Study of LILRA6 CAR-T for the Treatment of R/R Acute Myeloid Leukemia
This study aims to evaluate the safety and efficacy of LILRA6-directed chimeric antigen receptor T cells (LILRA6 CAR-T cells) in patients with refractory or relapsed acute myeloid leukemia(AML).
- Trial name
- NCT07263906
- Testing
- Anti-LILRA6 CAR-T cells
- Where
- China
- Volunteers
- 48 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
KMT2A-rearranged, NPM1-mutant Refractory or Relapsed AML
Ziftomenib + Mezigdomide in Adolesc. and Adults w/ R/R AML
The purpose of this study is to evaluate the safety and tolerability of mezigdomide in combination with ziftomenib in adolescent and adult participants with either KMT2A-rearranged (KMT2A-r) or NPM1-mutant relapsed or refractory…
- Trial name
- NCT07355335
- Testing
- Ziftomenib, Mezigdomide
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- Massachusetts General Hospital
Relapsed/Refractory Acute Myeloid Leukemia
Efficacy/Safety of CPI-613 in Combination With HD Cyt. and Mito. vs HD Cyt. and Mito. in Older Patients With R/R AML
A Phase III study to evaluate the safety and efficacy of CPI-613® (devimistat) in combination with High Dose Cytarabine and Mitoxantrone in comparison with high dose Cytarabine and Mitoxantrone and control sub-groups: combination…
- Trial name
- NCT03504410
- Testing
- CPI-613 + High Dose Cytarabine and Mitoxantrone, High Dose Cytarabine and Mitoxantrone, Mitoxantrone, Etoposide and Cytarabine
- Where
- 60 sites in United States, Australia and 7 more
- Volunteers
- 200 people
- Sponsor
- Cornerstone Pharmaceuticals
R/R AML
Addition of Hydroxyurea to Fludarabine, Cytarabine, Idarubicin and Venetoclax Salvage Therapy for Adults With Relapsed or Refractory Acute Myeloid Leukemia
This study is evaluating a new treatment approach for adults with acute myeloid leukemia (AML) that has either returned after previous treatment or has not responded to treatment.
- Trial name
- FLAsH-IV-AML (NCT07766850)
- Testing
- Hydroxycarbamid
- Where
- Sweden
- Volunteers
- 26 people
- Sponsor
- Christer C Nilsson
Leukemia, Myeloid, Acute
HDM201 Added to CT in R/R or Newly Diagnosed AML
This is a multi-center open-label Phase I/II study investigating orally administered HDM201 in combination with chemotherapy in two populations: subjects with first line AML or subjects with relapsed/refractory AML.
- Trial name
- NCT03760445
- Testing
- HDM201, cytarabine, anthracycline
- Sponsor
- Novartis Pharmaceuticals
Acute Myeloid Leukemia
DEC-C and Thioguanine for R/R AML
The purpose of this study is to find out if oral decitabine-cedazuridine (Inqovi®) is effective, safe, and able to be tolerated without severe side effects when given with thioguanine (Tabloid®) in patients with acute myeloid…
- Trial name
- NCT06351306
- Testing
- Thioguanine (Tabloid ®), DecitabineCedazuridine (Inqovi ®)
- Sponsor
- Columbia University
Allogeneic Stem Cell Transplant Recipient, Blasts 10 Percent or More of Bone Marrow Nucleated Cells
Trial Testing Safety of IL-21 NK Cells for Induction of R/R AML
This phase I trial studies the side effects of donor natural killer (NK) cell therapy in treating patients with acute myeloid leukemia that has come back (recurrent) or has not responded to treatment (refractory).
- Conditions
- Allogeneic Stem Cell Transplant Recipient, Blasts 10 Percent or More of Bone Marrow Nucleated Cells, Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
- Trial name
- NCT04220684
- Testing
- Cytarabine Hydrochloride, Fludarabine, Membrane-bound Interleukin-21-Expanded Haploidentical Natural Killer Cells
- Where
- 2 sites in United States
- Volunteers
- 19 people
- Sponsor
- Sumithira Vasu
AML
NK Cell Therapy for AML
This is a single-arm, open-label, non-randomized, multiple-dose, phase 1 dose escalation study evaluating the safety, efficacy and PK of CT101a in patients with relapsed/refractory acute myeloid leukemia.
- Trial name
- NCT05256277
- Testing
- CT101a
- Where
- China
- Volunteers
- 3 people
- Sponsor
- Zhejiang University
Acute Myeloid Leukemia
A Study to Evaluate HMPL-306 in Patients With IDH1or IDH2-mutated Acute Myeloid Leukemia
This study is a multicenter, randomized, open-label, phase III clinical study (RAPHAEL) to evaluate the efficacy, safety, and PK of HMPL-306 versus salvage chemotherapy in patients with R/R AML harboring IDH1 and IDH2 mutations.
- Trial name
- NCT06387069
- Testing
- HMPL-306 Regimen, Salvage Chemotherapy Regimen
- Where
- 53 sites in China
- Volunteers
- 316 people
- Sponsor
- Hutchmed